# Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/use-of-a-drug-master-file-for-shared-system-rems-submissions-guidance-for-industry/bdcae9f2-6712-48b2-afb3-be17664f8562

> FDA guidance document: Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry. Issue date: November 09, 2017. Get complete insights and analysis.

---

## Details

- Title: Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2017-11-09
- Last Changed: 2020-05-08
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-6231">FDA-2017-D-6231</a>

## Related Documents

- [Drug Master Files Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/drug-master-files-guidance-for-industry/7dfd5140-3156-43f2-bdb9-d23ad597311c)
- [Nonproprietary Naming of Biological Products: Update Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/nonproprietary-naming-of-biological-products-update-guidance-for-industry/8adaef5a-6903-4e65-ac57-121d51429730)
- [Development of a Shared System REMS Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/development-of-a-shared-system-rems-guidance-for-industry/b67470fa-28bc-4644-aeba-c9afd830c0cd)